DUBLIN, Nov. 19, 2019 /CNW/ -- Endo International plc
(NASDAQ: ENDP) announced today that the U.S. Food and Drug
Administration (FDA) has accepted for review the original Biologics
License Application (BLA) for collagenase clostridium histolyticum
(CCH) for the treatment of cellulite in the buttocks. The
Prescription Drug User Fee Act (PDUFA), or target action date for
the BLA, has been set for July 6,
2020.
"We have confidence in and are excited by the promising results
of our CCH for cellulite program, which encompasses the largest
U.S. clinical trials for the treatment of cellulite in
history1," said Paul
Campanelli, Endo's Chairman, President and Chief Executive
Officer. "Acceptance of our BLA is a significant milestone and we
look forward to advancing the next steps to bring this treatment to
aesthetic physicians and their patients."
The BLA is supported by the results of the RELEASE*-1 and
RELEASE-2 Phase 3 studies, as well as a robust clinical and
pre-clinical program.
About Cellulite
Cellulite is a localized alteration in the contour of the skin
that has been reported in 85 to 98 percent of post-pubertal females
and affects women of all races and ethnicities.2,3 The
primary cause of the condition is a thickening of the collagen
septae that attach the skin to the underlying fascia layers with
additional contributing protrusions of subcutaneous fat. The septae
tether the skin, which causes the surface dimpling characteristic
of cellulite.3,4 Cellulite clinically presents on the
buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized
obesity. In generalized obesity, adipocytes undergo hypertrophy and
hyperplasia that are not limited to the pelvis, thighs, and
abdomen.5 In areas of cellulite, characteristic large,
metabolically stable adipocytes have physiologic and biochemical
properties that differ from adipose tissue located elsewhere.
Weight gain makes cellulite more noticeable, but it may be present
even in thin subjects. Genetics may also play a role, since
cellulite tends to run in families.
Despite multiple therapeutic approaches for the attempted
treatment of patients with cellulite, there are currently no
FDA-approved injectable treatments on the market.6
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly-focused
generics and specialty branded pharmaceutical company delivering
quality medicines to patients in need through excellence in
development, manufacturing and commercialization. Endo has global
headquarters in Dublin, Ireland,
and U.S. headquarters in Malvern,
PA. Learn more at www.endo.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including, but not
limited to, the statements by Mr. Campanelli, and other statements
regarding FDA's review process, timing and results, research and
development outcomes, efficacy, adverse reactions, market and
product potential and product availability. Statements including
words such as "believes," "expects," "anticipates," "intends,"
"estimates," "plan," "will," "may," "look forward," "intend,"
"guidance," "future" or similar expressions are forward-looking
statements. Because these statements reflect Endo's current views,
expectations and beliefs concerning future events, they involve
risks and uncertainties. Although Endo believes that these
forward-looking statements and information are based upon
reasonable assumptions and expectations, readers should not place
undue reliance on them, or any other forward-looking statements or
information in this news release. Investors should note that many
factors, as more fully described in the documents filed by Endo
with the Securities and Exchange Commission and with securities
regulators in Canada on the System
for Electronic Document Analysis and Retrieval, including under the
caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K
filings, and as otherwise enumerated herein or therein, could
affect Endo's future results and could cause Endo's actual results
to differ materially from those expressed in forward-looking
statements contained in this communication. The forward-looking
statements in this press release are qualified by these risk
factors. Endo assumes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise, except as may be required under
applicable securities laws.
*Randomized EvaLuation
of CEllulite Reduction by
CollAgenaSE Clostridium Histolyticum
(RELEASE)
References
- US National Library of Medicine. ClinicalTrials.gov. National
Institutes of Health. Accessed March 19,
2019.
- Avram M. Cellulite: a review of its physiology and treatment,
Journal of Cosmetic Laser Therapy 2004; 6: 181–185.
- Khan MH et al. Treatment of cellulite: Part I.
Pathophysiology. J Am Acad Dermatol. 2010
Mar;62(3):361-70.
- Querleux B et al. Anatomy and physiology of subcutaneous
adipose tissue by in vivo MRI and spectroscopy: Relationship with
sex and presence of cellulite, Skin Research and Technology;
8: 118-124.
- Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite:
Part I. Pathophysiology. J Am Acad Dermatol
2010;62(3):361-370.
- Zerini I et al. Cellulite treatment: a comprehensive literature
review. J Cosmet Dermatol. 2015 Sep 14(3):224-40
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SOURCE Endo International plc